Chemistry International
Vol. 21, No. 3
May 1999
New
Books and Publications
New
Books from the World Health Organization
WHO Expert Committee on Biological
Standardization, 47th Report, Technical Report Series No. 878
1998, vi + 101 pages (available in English; French and
Spanish in preparation), ISBN 92 4 120878 3, CHF 20.-/USD 18.50; In
developing countries: CHF 14, Order no. 1100878. WHO distribution and
sales, CH-1211 Geneva 27, Switzerland.
This report presents the recommendations of a WHO expert
committee commissioned to coordinate a range of research and other activities
needed to assure the purity, potency, safety, and stability of biological
products used in medicine. Work includes the development and adoption
of detailed requirements for the manufacturing, licensing, and control
of vaccines and other biologicals. The committee also coordinates the
establishment of international reference materials for measuring the
potency and other characteristics of biological products. These reference
materials are used worldwide and play a crucial role in ensuring the
comparability of products on a global basis.
The report has three parts. The first provides a brief
discussion of general issues that shape the committee's work. Issues
discussed include the implications of reverse transcriptase activity
in avian cells, the need for reference preparations for evaluating hepatitis
B, hepatitis C, and HIV diagnostic kits, and progress toward the standardization
of gene-amplification methods for the viral safety testing of blood
and blood products. The second part summarizes activities relating to
the status of some 24 biological reference preparations categorized
as antibiotics, antibodies, blood products and related substances, cytokines,
endocrinological and related substances, toxins, and other substances.
The third and most extensive part issues detailed requirements
for the use of animal cells as in vitro substrates for the production
of biologicals, guidelines for the production and control of the acellular
pertussis component of monovalent or combined vaccines, and guidelines
for assuring the quality of DNA vaccines.
Basic Tests for Drugs, Pharmaceutical
Substances, Medicinal Plant Materials, and Dosage Forms
1998, iii + 91 pages (available in English; French and
Spanish in preparation) ISBN 92 4 154513 5 CHF 26.-/USD 23.40; In developing
countries: CHF 18.20, Order no. 1150462
This book provides a step-by-step guide to simple methods
for verifying the identity of commonly used pharmaceutical substances
and dosage forms. The basic tests described can also be used to detect
mislabeled, substandard, or counterfeit products when the labeling or
physical attributes give rise to doubt. Intended for use in developing
countries, where resources and specialized skills may be scarce, all
tests rely on a limited range of easily available reagents and equipment
and need not be performed in a fully equipped laboratory or by persons
with specialized training in pharmacy or chemistry.
The book describes tests for 23 pharmaceutical substances
and 58 pharmaceutical dosage forms, most of which are included in the
WHO Model List of Essential Drugs. Basic tests for confirming the identity
of four commonly used medicinal plant materials are also included. As
stressed in the text, these tests, which merely confirm identity, are
intended for use as primary screening tools and may need to be followed,
in cases of adverse test results, by a full pharmacopoeial analysis.
The book opens with a brief description of the importance
of basic tests as one of the many steps needed to ensure a supply of
safe and effective drugs. Chapter 2 describes several collections of
more sophisticated tests, including volumetric or spectrophotometric
analysis and thin-layer chromatography, that can be useful in the primary
screening of imported pharmaceutical substances and dosage forms. Information
on how to obtain and use these guides to tests, which have not been
published by WHO, is also provided.
Against this background, the main part of the book sets
out test procedures for verifying the identity of selected pharmaceutical
substances, pharmaceutical dosage forms, and medicinal plant materials.
The book concludes with a cumulative index of test procedures described
here and in the related WHO publications, Basic Tests for Pharmaceutical
Substances and Basic Tests for Pharmaceutical Dosage Forms.
Quality Control Methods for Medicinal
Plant Materials
1998, viii + 115 pages (available in English; French and
Spanish in preparation), ISBN 92 4 154510 0, CHF 35.-/USD 31.50; In
developing countries: CHF 24.50, Order no. 1150451.
This manual provides a collection of recommended test
procedures for assessing the identity, purity, and content of medicinal
plant materials. Intended to assist national laboratories engaged in
drug quality control, the manual responds to the growing use of medicinal
plants, the special quality problems they pose, and the corresponding
need for international guidance on reliable methods for quality control.
Recommended procedures-whether involving visual inspection or the use
of thin-layer chromatography for the qualitative determination of impurities-should
also prove useful to the pharmaceutical industry and pharmacists working
with medicinal plant materials.
Test procedures are intended to support the development
of national standards based on local market conditions, with due regard
to existing national legislation and national and regional norms. The
book also includes advice on general limits for pesticides and other
contaminants commonly found in medicinal plant materials.
The book opens with a brief discussion of general principles
for the analysis of plant materials, including advice on the special
handling procedures required during sampling, and guidance on macroscopic
and microscopic examination as the first step toward establishing the
identity and degree of purity of plant materials. Subsequent chapters
describe procedures for the determination of foreign matter, ash, extractable
matter, water and volatile matter, volatile oils, bitterness value,
haemolytic activity, tannins, swelling index, and foaming index. Where
relevant, suitable test apparatuses are illustrated and explained.
Additional chapters set out test methods for the determination
of such important contaminants as pesticide residues, arsenic and heavy
metals, and microorganisms, including aflatoxins. The remaining chapters
cover procedures for preparing culture media, strains of microorganisms
suitable for use in tests, specifications for adsorbents for use in
thin-layer chromatography, and detailed descriptions of the reagents,
test solutions, and volumetric solutions used in the recommended tests.